Convener of Active Medical Product Surveillance Discussion (U13), 30097-30098 [E9-14904]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 74, Number 120 (Wednesday, June 24, 2009)]
[Notices]
[Pages 30097-30098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-14904]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0275]


Convener of Active Medical Product Surveillance Discussion (U13)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of grant funds for the support of a neutral, independent 
institution and/or organization that proposes appropriate methods and 
processes for convening a broad range of stakeholders with relevant 
expertise to manage and support conferences and meetings. The focus of 
the conferences and meetings is to explore and address methodological, 
data development, technical, and communication issues related to active 
medical product surveillance. The awardee would be expected to 
synthesize, summarize, and communicate findings from these conferences 
and meetings to a broad range of organizations and individuals who have 
the capability to use the information to further develop and create 
active medical product surveillance methods and systems.

DATES: The application due date is July 15, 2009. The earliest start 
date is in September 2009.

FOR FURTHER INFORMATION AND ADDITIONAL REQUIREMENTS CONTACT:
    Programmatic/Peer Review Contact: Melissa Robb, Office of Critical 
Path Programs, Office of the Commissioner, Food and Drug 
Administration, 5600 Fishers Lane, rm. 14B-45, Rockville, MD 20857, 
301-827-1516, e-mail: melissa.robb@fda.hhs.gov.
    Financial or Grants Management Contact: Gladys M. Bohler, Office of 
Acquisitions and Grant Services, Food and Drug Administration, 5630 
Fishers Lane, rm. 2105, Rockville, MD 20857, 301-827-7168, FAX: 301-
827-7101, e-mail: gladys.bohler@fda.hhs.gov.
    For more information on this funding opportunity announcement (FOA) 
and to obtain detailed requirements, please refer to the full FOA 
located at https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149345.htm.

SUPPLEMENTARY INFORMATION:

I. Funding Opportunity Description

Request for Applications (RFA) Number: RFA-FD09-012
Catalog of Federal Domestic Assistance Number: 93.103

A. Background

    In 2007, Congress enacted the Food and Drug Administration 
Amendments Act of 2007 (FDAAA). Section 905 of this statute calls for 
the Secretary of Health and Human Services (the Secretary) to develop 
methods to obtain access to disparate data sources and to establish an 
active postmarket risk identification and analysis system that links 
and analyzes safety data from multiple sources. The law sets a goal of 
access to data from 25 million patients by July 1, 2010, and 100 
million patients by July 1, 2012. The law also requires FDA to work 
closely with partners from public, academic, and private entities.
    In May 2008, the Secretary and the Commissioner of Food and Drugs 
announced the launch of the Sentinel Initiative, a long-term effort to 
create a national electronic system for monitoring regulated product 
safety. Once implemented, the Sentinel System is intended to augment 
FDA's existing postmarket (primarily passive) safety surveillance 
systems and to enable FDA to actively gather information about the 
postmarket safety and performance of its regulated products. FDA views 
its Sentinel Initiative as a mechanism through which some of the 
requirements mandated in FDAAA can be carried out.
    As currently envisioned, the Sentinel System will enable FDA to 
capitalize on the capabilities of multiple, existing automated 
healthcare data systems (e.g. electronic health record systems, 
administrative claims databases, registries). The Sentinel System will 
enable queries of disparate data sources quickly and securely for 
relevant regulated product safety information. Data will continue to be 
managed by its owners, and only data of organizations who agree to 
participate in this system will be involved. FDA questions would be 
sent to appropriate, participating data holders, who would, in 
accordance with existing privacy and security safeguards, evaluate 
their data and send results summaries to FDA for review.
    Following announcement of the Sentinel Initiative in May 2008, 
FDA's first step has been to create a broad public forum for discussion 
of issues related to developing and implementing the Sentinel System. 
During 2008, FDA sponsored a series of exploratory meetings with a 
broad variety of stakeholders to identify key issues that will need to 
be addressed before, during, and after implementation of the Sentinel 
System. Key questions include, for example, what level of collaboration 
between public and private entities would best ensure the success of 
the initiative; how a possible governance model could be identified and 
developed; what kind of methods and tools will be needed to facilitate 
the

[[Page 30098]]

development and sharing of highly technical summary results derived 
from automated healthcare data in disparate systems; and what privacy 
and security safeguards will be needed and how will they be maintained.

B. Research Objectives

    These initial discussions have focused on many of the policy and 
procedural needs of developing the Sentinel System. However, to 
proceed, additional meetings and working groups need to be formed to 
explore in greater depth the science of safety needed to support this 
initiative, as well as methods for communicating about the information 
learned from the system. Topics to be addressed include specific 
topics, issues, and questions related to the development of active 
medical product surveillance methodologies and tools. Subsequently, the 
information from these meetings and working groups must be described, 
managed, and made available to the public using a transparent and open 
approach.

C. Eligibility Information

    The following organizations/institutions are eligible to apply: 
Non-profit organizations.
    Foreign institutions are not eligible to apply for conference grant 
support. An international conference can be supported through the U.S. 
representative organization of an established international scientific 
or professional society.

II. Award Information/Funds Available

A. Award Amount

    FDA anticipates providing up to $600,000 (direct cost only) during 
fiscal year (FY) 2009 to support efforts outlined in this FOA. One 
award will be made.
    This Cooperative Agreement ensures substantial FDA involvement in 
this program and will include, but not be limited to, co-development of 
the meeting(s) priorities and agendas and providing feedback on reports 
and publications related to meeting proceedings on identified topics.

B. Length of Support

    Subject to the availability of Federal funds and successful 
performance, and if the FOA stated objectives are met, an additional 4 
years of support up to $600,000 (direct and indirect costs combined) 
per year may be available.

III. Electronic Application, Registration, and Submission

    Only electronic applications will be accepted. To submit an 
electronic application in response to this FOA, applicants should first 
review the full announcement located at https://www.fda.gov/Safety/FDAsSentinelInitiative/ucm149345.htm.
    For all electronically submitted applications, the following steps 
are required.
     Step 1: Obtain a Dun and Bradstreet (DUNS) Number
     Step 2: Register With Central Contractor Registration
     Step 3: Obtain Username & Password
     Step 4: Authorized Organization Representative (AOR) 
Authorization
     Step 5: Track AOR Status
     Step 6: Register With Electronic Research Administration 
(eRA) Commons
    Steps 1 through 5, in detail, can be found at https://www07.grants.gov/applicants/organization_registration.jsp. Step 6, in 
detail, can be found at https://commons.era.nih.gov/commons/registration/registrationInstructions.jsp. After you have followed 
these steps, submit electronic applications to https://www.grants.gov.

    Dated: June 19, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-14904 Filed 6-23-09; 8:45 am]
BILLING CODE 4160-01-S